Pricing / Pharmacovigilance
PPB QPPV Compliance Required

Pharmacovigilance Pricing

Transparent pricing for PV system setup, QPPV nomination, ADR reporting, PSUR preparation, and ongoing pharmacovigilance support for Kenyan MAHs.

Choose the Right PV Package

From initial PV system setup to ongoing retainer support - we cover every obligation the PPB requires of a Marketing Authorisation Holder.

PV System Setup

Build a PPB-compliant PV system from scratch

KES 180K - 350K

Timeline: 6-10 weeks

  • PV System Master File (PSMF) drafting
  • PV SOPs (ADR intake, signal detection, PSURs, literature monitoring)
  • Risk Management Plan (RMP) template
  • Staff training on PV workflows
  • PPB PvERS registration support
Get Custom Quote

QPPV Nomination

Qualified Person for Pharmacovigilance - PPB-registered

KES 40K - 80K / month

12-month minimum retainer

  • PPB-qualified QPPV officially nominated to your MAH
  • 24/7 ADR intake email & hotline
  • ICSR triage, medical review & CIOMS/E2B submission
  • Monthly signal detection review
  • PPB PV audit representation & response
  • Monthly PV activity report to the MAH
Get Started
PPB REQUIRED FOR MAHs

PSUR / PBRER Preparation

Periodic safety update report per ICH E2C(R2)

KES 80K - 200K / report

Per product, per reporting interval

  • Full PBRER drafting per ICH E2C(R2)
  • Literature search & signal evaluation
  • Benefit-risk evaluation
  • PPB submission & query response
  • SmPC / CCDS update recommendations
Get Custom Quote

Additional PV Services

Specific PV tasks charged ad-hoc when you need them.

Ad-hoc ICSR processing

KES 5K - 12K / case

One-off adverse event cases processed, medically reviewed, and submitted to PPB PvERS. Pricing depends on seriousness & complexity.

PV training (half-day workshop)

KES 40K - 80K

Classroom or on-site training for sales reps, medical, or call-centre teams on recognising and reporting adverse events.

Risk Management Plan (RMP)

KES 120K - 250K

Product-specific RMP drafted for PPB submission - safety specification, pharmacovigilance plan, and risk minimisation measures.

PV audit (internal)

KES 80K - 180K

Independent audit of your PV system against PPB guidelines - gap analysis, corrective actions, and CAPA tracking.

Literature monitoring (per product)

KES 8K - 15K / month

Weekly literature search across PubMed, Embase, and local journals for safety-relevant publications on your product.

PvERS account setup & training

KES 25K - 50K

Full onboarding to PPB's Pharmacovigilance Electronic Reporting System including account setup, user provisioning, and hands-on training.

Who Needs Pharmacovigilance?

PPB now requires every Marketing Authorisation Holder in Kenya to operate a functional PV system with a nominated QPPV.

Marketing Authorisation Holders

Every MAH for a product registered in Kenya must have a functional PV system - mandatory since the 2022 PPB guideline.

Importers & Distributors

If you import and distribute registered products for the Kenyan market, you inherit PV obligations from the foreign MAH.

Clinical Trial Sponsors

PV obligations during clinical trials - SUSAR reporting, DSURs, and ongoing safety monitoring of investigational products.

Pharmacovigilance FAQs

Do I really need a QPPV in Kenya?

Yes. PPB requires every MAH for a registered pharmaceutical product in Kenya to nominate a Qualified Person for Pharmacovigilance. The QPPV must be a registered pharmacist based in Kenya and reachable 24/7.

Can I use my foreign QPPV?

No - PPB requires a Kenya-based QPPV. However, your foreign QPPV can remain the global safety lead; our local QPPV operates as the designated local contact and coordinates with your global PV function.

How often must PSURs be submitted to PPB?

Typically 6-monthly for the first 2 years after authorisation, annually for years 3-5, then 3-yearly. Exact frequency is set in each product's approval conditions.

What's the penalty for not having a PV system?

PPB can suspend or revoke product registrations and refuse renewal applications. Repeat non-compliance can lead to enforcement action against the MAH.

Do you serve clients outside Nairobi?

Yes. QPPV services are delivered remotely as standard. Audits and training can be done on-site across Kenya; travel costs are quoted transparently.

Get PV-Compliant Before Your Next PPB Audit

Book a 30-minute strategy call with our QPPV. We'll assess your current PV posture and propose a package that fits.

Book Strategy Call

Free initial consultation - No obligation - Same-day response